A double-blind comparative study of S 6472 (a long-acting cefaclor) versus a conventional cefaclor preparation in complicated urinary tract infections

For an objective evaluation of the clinical efficacy, safety and usefulness of S 6472 (a long acting cefaclor) in non-catheterized patients with complicated urinary tract infections, a double-blind comparative study was performed using conventional cefaclor preparation (hereafter, CCL) as the control drug. S 6472 was administered orally at a single dose of 750 mg twice daily, and CCL at a single dose of 500 mg 3 time daily. The duration of the treatment was 5 days for either drug. Clinical efficacies were evaluated according to the criteria for evaluation of drug efficacy by the Japanese UTI Committee (3rd edition), and the following results were obtained. 1. The initial distribution of the patients' background characteristics was not significantly different between the S 6472 and CCL groups. 2. The overall clinical efficacy rates were 76.2% in the S 6472 group and 75.5% in the CCL group, indicating no significant difference between the 2 groups. When clinical efficacies evaluated according to different types of infections (UTI groups), the differences between the 2 drug groups were not significant in any of disease groups 2, 3, 4, and 6. 3. Clinical efficacy rates as evaluated by attending physicians were not significantly different between the 2 groups, either. 4. Bacteriological responses were evaluated as eradicated in 81.2% in the S 6472 group and 78.3% in the CCL group, suggesting no statistically significant difference. 5. The incidences of side effects were 2.9% (4/139) in the S 6472 group and 0.7% (1/141) in the CCL group, thus no significant differences existed between the 2 groups. On laboratory examination, 4 and 5 abnormal test values, respectively, were detected in 3/94 patients in the S 6472 group and 5/100 patients in the CCL group, but the difference was not significant between the 2 groups, either. All of these side effect symptoms and abnormal laboratory test values were mild in severity and transient. The results of the overall safety rating which was based on the evaluations of the side effects and laboratory test values indicated no significant difference between the 2 groups. 6. According to judgement by the attending doctors, the clinical usefulness rates evaluated based on the results of the efficacy and safety ratings were not significantly different between the S 6472 and CCL groups. These findings suggest that S 6472 produces excellent therapeutic results in complicated UTI patients without indwelling catheters and its clinical efficacy, safety, and usefulness are equal to those of the conventional CCL.(ABSTRACT TRUNCATED AT 400 WORDS)     

Correlation between histological grading and the prognosis of prostatic carcinoma--a comparative study of the Japanese General Rules of Prostatic Cancer (JGRPC) and Gleason's classification

One hundred and sixty-seven patients with newly diagnosed, previously untreated prostatic adenocarcinoma, during the period between July, 1971 and March, 1934, were studied. The histopathologic specimens of the prostate were classified by the Japanese General Rules of Prostatic Cancer (JGRPC) and by Gleason's classification. The number of patients with well, moderately and poorly differentiated prostatic carcinomas according to the JGRPC classification was 42, 74 and 51 respectively, and the number of the patients with Gleason's pattern 1, 2, 3, 4, and 5 was 24, 20, 32, 43 and 48, respectively. The number of patients with Gleason's score (primary plus secondary pattern) 2 to 4, 5 to 7 and 8 to 10 groups was 40, 76 and 51 respectively. There was no significant difference in survival rate between well and moderately differentiated groups, but the survival rate of the group with poorly differentiated tumor was significantly lower than that of the moderately differentiated (p less than 0.01) and well differentiated (p less than 0.001) groups. There was no significant difference in 10-year survival rate between the score 2-4 and score 5-8 groups, but the score 9-10 group had a significantly lower survival rate than the score 5-8 group (p less than 0.01) and score 2-4 (p less than 0.005) group. JGRPC and Gleason's classification are thought to be equally useful in estimating prognosis of prostatic cancer, but the former is more concise and easily applicable than the latter.     

The pharmacokinetics of cisplatin and its influence on renal function according to different infusion methods (report II)--alleviation of renal impairment by bismuth subnitrate combined with ginseng and tang-koui ten

In the previous report, we discussed in vivo dynamics and renal impairment resulting from the difference in cisplatin CDDP administration. In the present study, we investigated in vivo dynamics and renal impairment under 1 h of continuous drip infusion of CDDP. The free-type Pt concentration ratio, which is considered to indicate antitumor activity in the overall plasma Pt concentration at the end of the administration, was noted to be approximately 64%. This was significantly higher than other administration methods, making this an effective administration procedure. However, NAG, which is considered to be an index of renal impairment along with the amount of beta 2-microglobulin urine excretion, showed higher values than those by other administration methods. Thus, using the 1-hr continuous CDDP drip infusion, we attempted to alleviate the renal impairment, combining bismuth subnitrate with ginseng and Tang-koui ten. As a result, the amount of beta 2-microglobulin excretion in the urine was diminished as well as NAG, and a reduction of the renal impairment was noted. These alleviational effects of the renal impairment were attributed to the method of consistent oral administration by which alleviation could take place with little load on the patient.     

The synaptic relationship between vasoactive intestinal polypeptide (VIP)-like immunoreactive neurons and their axon terminals in the rat small intestine: light and electron microscopic study

The present study demonstrates synaptic contacts between vasoactive intestinal polypeptide (VIP)-like immunoreactive neurons and immunoreactive axon terminals in the submucous and myenteric plexuses of the rat small intestine. Our observations suggest that VIP afferents directly affect the VIP neurons in the small intestine via synapses.     

Original Articles: Comparative Studies on Interaction Between Theophylline and Quinolones

A comparative study of the pharmacokinetic and metabolic interactions between theophylline and a newly developed quinolone, T-3262, was carried out under steady-state conditions in seven healthy male volunteers, using enoxacin as the reference drug. A sustained-release theophylline formulation (200 mg twice daily) was given as monotherapy and coadministered with T-3262 (150 mg three times a day) or enoxacin (200 mg three times a day). The total and free concentrations of theophylline in the plasma and the excreted concentration of theophylline and its metabolites in the urine were measured by a highperformance liquid chromatography method. The mean steady-state plasma theophylline concentration significantly increased by approximately 1.5-fold and threefold after coadministration of T-3262 and enoxacin, respectively. In both cases, a significant decrease in the total body clearance was found for T-3262 (34%) and enoxacin (63%), but the plasma protein binding of theophylline remained unchanged. There was a significant increase in urinary theophylline and a decrease in urinary 3-methylxanthine after coadministration of T-3262 or enoxacin. The degree of change in the steady-state plasma theophylline concentration as a result of coadministration of T-3262 was small compared to that of enoxacin. A decrease in the total body clearance in the case of coadministration of a quinolone probably resulted from inhibition of the 1-demethylation metabolic pathway.